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在基层医疗机构的神经科医生/疼痛治疗师的实践中使用夫罗曲坦:ALADIN 上市后监测研究的结果。

Frovatriptan in the practice of office-based neurologists/pain therapists: Results of postmarketing surveillance study ALADIN.

机构信息

Headache Center of Clinic for Interdisciplinary Pain Therapy, Sankt Gertrauden Hospital, Kopf-Schmerzzentrum am Sankt Gertrauden-Krankenhaus, Berlin, Germany.

出版信息

Adv Ther. 2010 Jan;27(1):56-62. doi: 10.1007/s12325-010-0001-1. Epub 2010 Feb 6.

DOI:10.1007/s12325-010-0001-1
PMID:20140543
Abstract

INTRODUCTION

Large postmarketing surveillance (PMS) studies have demonstrated the efficacy and tolerability of frovatriptan for treatment of acute migraine in patients attending general practitioners (GPs). The aim of the ALADIN (Allegro Anwendung durch interessierte Neurologen [Allegro application by interested neurologists]) PMS study was to evaluate frovatriptan in patients attending neurologists or pain therapists.

METHODS

Patients fulfilling International Headache Society criteria for migraine, with or without aura, were enrolled. Patients completed an attack diary, including details of the attack, time to onset of action of frovatriptan, and recurrence of headache. Physicians completed a case report form detailing prior and actual migraine treatment. Frovatriptan 2.5 mg was administered for up to three consecutive attacks.

RESULTS

In total, 2160 patients were enrolled and data were obtained for 5831 attacks. Patients attending neurologists had more frequent attacks and longer history of migraine compared with those attending GPs. Median time to frovatriptan onset of action was 40 min and time to freedom from headache 70 min. An average of 1.2 frovatriptan tablets was required per attack, and mean additional analgesic use was 0.13. Recurrent headache occurred in 13.6%-15.5% of patients. Physicians as well as patients judged frovatriptan onset and duration of action as at least "good" in approximately 80% of attacks. A similar number judged the efficacy of frovatriptan against headache as "better" than previous treatment. The study drug was generally well tolerated. The frequency of adverse events was 0.6%.

CONCLUSION

Frovatriptan, with fast onset of action and low rate of headache recurrence, was efficacious and well accepted by migraineurs attending neurologists or pain therapists. Approximately 80% of patients wished to continue migraine treatment with frovatriptan.

摘要

介绍

大量的上市后监测(PMS)研究表明,曲普坦治疗偏头痛急性发作的疗效和耐受性,在接受全科医生(GP)治疗的患者中得到了证实。ALADIN(Allegro Anwendung durch interessierte Neurologen [Allegro 由感兴趣的神经科医生应用])PMS 研究的目的是评估曲普坦在接受神经科医生或疼痛治疗师治疗的患者中的疗效。

方法

符合国际头痛协会偏头痛标准的患者(伴或不伴先兆)被纳入研究。患者填写发作日记,记录发作细节、曲普坦起效时间和头痛复发情况。医生填写病例报告表,详细说明既往和当前偏头痛的治疗情况。曲普坦 2.5mg 最多连续使用 3 次。

结果

共纳入 2160 例患者,获得了 5831 次发作的数据。与 GP 就诊的患者相比,就诊于神经科医生的患者发作频率更高,偏头痛病史更长。曲普坦起效的中位数时间为 40 分钟,头痛缓解的中位数时间为 70 分钟。平均每个发作需要使用 1.2 片曲普坦,平均额外使用止痛药 0.13 片。13.6%-15.5%的患者出现头痛复发。医生和患者对曲普坦的起效和作用持续时间的评价约为“良好”,约 80%的患者对头痛的缓解效果评价为“优于”既往治疗。研究药物总体耐受性良好。不良反应的发生率为 0.6%。

结论

曲普坦起效迅速,头痛复发率低,对接受神经科医生或疼痛治疗师治疗的偏头痛患者有效,且患者接受度高。约 80%的患者希望继续使用曲普坦治疗偏头痛。

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